BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4412341 · Received January 9, 2015

    Report

    Report Number
    1052693-2015-00008
    Event Type
    Malfunction
    Date Received
    January 9, 2015
    Date of Event
    December 10, 2014
    Report Date
    December 30, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE IS: STRIP REUSED, STRIPS STORED IN HIGH ENVIRONMENT STORAGE CONDITION, NO CHEMISTRY ON STRIP.

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED EVALUATION. (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". I RAN A BACK TO BACK BLOOD TEST, LO AND LO. CUSTOMER STATES THAT HER NORMAL RANGE IS AROUND 165 MG/DL. REVIEWED THE LAST 5 BLOOD RESULTS IN THE METER MEMORY; 1. LO. 2. LO. 3. LO. 4. LO 5. LO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23546 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1647

    Patients

    Seq Age Sex Outcome Treatment
    1